Final draft NICE guidance recommends icosapent ethyl (Vazkepa) for secondary prevention of cardiovascular events in adults with established cardiovascular disease who are at high risk of such events, if they have controlled LDL-cholesterol levels (>1.04mmol/L and ≤2.60mmol/L) but raised triglycerides (≥1.7mmol/L) despite taking a statin.
Established cardiovascular disease is defined as a history of acute coronary syndrome, coronary or other arterial revascularisation procedures, coronary heart disease, ischaemic stroke or peripheral arterial disease.
NHS England estimates that between 25% and 35% of people on statin therapy have elevated triglycerides. NICE says up to 425,000 people could benefit from treatment with icosapent ethyl, which is the first licensed drug shown to reduce the risk of cardiovascular events in people with controlled LDL-C and raised triglycerides who are taking a statin.
NICE's final draft recommendation represents a reversal of its initial position on use of the drug in people with cardiovascular disease, following feedback from consultation. NICE originally rejected the drug for use in this setting, noting that clinical trials compared it with a mineral oil placebo that may itself increase cardiovascular risk. In addition, NICE said the pivotal REDUCE-IT trial on which marketing authorisation was based did not include any people from the UK or represent the country's ethnic diversity.
There is no change to NICE's draft decision not to recommend icosapent ethyl for primary prevention in people without established cardiovascular disease, for which NICE said the drug was 'unlikely to be cost-effective'.
Clinical trial evidence suggests that for people with raised triglycerides who have LDL-C levels controlled by statins, and who have cardiovascular disease, icosapent ethyl reduces their risk of cardiovascular events by over a quarter compared with placebo.
Helen Knight, interim director of medicines evaluation at NICE, said: 'Icosapent ethyl is the first licensed treatment of its kind for people who are at risk of heart attacks and strokes despite well controlled LDL cholesterol because they have raised blood fats. And although lifestyle changes, including diet and exercise, can help to reduce their risk, these may not work for everyone.
'We have worked closely with the company [that markets Vazkepa] to identify the population most likely to gain the greatest benefit from icosapent ethyl, striking a balance between effectiveness and the best use of public funding, delivering maximum value to the taxpayer.'
Stakeholders have the opportunity to appeal against the recommendations in the final draft guidance. If no appeals are received, the final technology appraisal is expected to be published on 13 July.